Pro-Select Platinum® S40750

GUDID D813S407500

PSP 6 ft. Autoclave LED Cable

DEN-MAT HOLDINGS, LLC

Ultrasonic dental scaling/debridement system Ultrasonic dental scaling/debridement system

• Primary Device ID: D813S407500
• NIH Device Record Key: 0d4defce-94d4-4c8d-8310-97b7f30daa0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Select Platinum®
• Version Model Number: S40750
• Catalog Number: S40750
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from explosive substances and flammable materials
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813S407500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964596

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D813S407500]

High-level Disinfectant;Moist Heat or Steam Sterilization;Liquid Chemical

[D813S407500]

High-level Disinfectant;Moist Heat or Steam Sterilization;Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• D813S42350L0: PSP STANDARD PACK LOANER
• D813S423500: PSP STANDARD PACK
• D813S409010: PSP Foot Pedal
• D813S408710: PSP LED Light Attachments
• D813S408510: PSP Irrigation Handpiece
• D813S408010: PSP SCALER HANDPIECE
• D813S407500: PSP 6 ft. Autoclave LED Cable
• D813S309601: PSP TIPS – UNIV STRT 3PK
• D813S309500: PSP TIP – UNIV RIGHT
• D813S309400: PSP TIP – UNIV LEFT
• D813S309300: PSP TIP – UNIV STRT
• D813S30921: PSP TIPS – L/R/STRT 3PK
• D813S30500: Transformer/Adapter + Wall Plug (Universal for PSP & PS3)
• D81320540: 23-Gauge Sideport Irrigation Cannulas (100/box)
• D8131007730: Tip Gauge/ Wrench
• D8131005400: Tip Grip